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MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)

*Les informations de l'essai contenues sur cette page ont été récupérées du site ClinicalTrials.gov. Cliquez ici pour voir cet essai sur ClinicalTrials.gov.

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Titre complet:
A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY
Stade ou Condition:
Multiple Myeloma
Phase d'étude:
Phase 3
Résumé:
The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: - Are 18 years of age or older and have MM. - Have received treatments before for MM. - Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: - a shot under the skin at the study clinic - through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.
Description détaillée:
Non disponible
Traitements:
Drug : Elranatamab

Elranatamab will be administered subcutaneously

Drug : Elotuzumab

Elotuzumab will be administered intravenously

Drug : Pomalidomide

Pomalidomide will be administered orally

Drug : Dexamethasone

Dexamethasone will be administered orally

Drug : Bortezomib

Bortezomib will be administered subcutaneously or intravenously

Drug : Carfilzomib

Carfilzomib will be administered intravenously

Groupes d'étude:
Experimental : Elranatamab
Participants will receive elranatamab monotherapy
Active Comparator : Investigator's Choice
Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
Type d'étude:
Interventional
Protocole de l'étude:
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)
Statut du recrutement:
En cours
Critères d'admissibilités:
Inclusion Criteria:
  • Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.
  • Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.
  • Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
  • Have clinical laboratory values within the specified range.
  • ECOG (Eastern Cooperative Oncology Group) performance status ≤2.
  • Not pregnant or breastfeeding and willing to use contraception.
Exclusion Criteria:
  • Smoldering multiple myeloma.
  • Plasma cell leukemia.
  • Amyloidosis.
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
  • Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
  • Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
  • Any active, uncontrolled bacterial, fungal, or viral infection.
  • Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
  • Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
  • Unable to receive investigator's choice therapy.
  • Live attenuated vaccine within 4 weeks of the first dose of study intervention.
  • Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
Lieux / Centres:

The Moncton Hospital, Moncton, New Brunswick – À venir

Jewish General Hospital, Montreal, Quebec – À venir

Contacts:
Name: Pfizer CT.gov Call Center
Phone: 1-800-718-1021
Email: [email protected]
Publications:
???
Date d’affichage:
2023-11-30
Date de début:
February 8, 2024
Dernière mise à jour:
2024-05-09
Nombre d'inscriptions anticipées:
492
Date de fin prévue:
2028-03-24
Date de fin prévue de l'étude primaire:
2025-12-20
Condition:
Multiple Myeloma
Genre:
All
Âge:
18 Years-N/A
Accepte des bénévoles en santé:
No
Pays participants:
Canada
Japan
United States
Numéro d’identification:
NCT06152575
Autres numéros d'identification de l'étude:
C1071032
Comité de suivi des données:
Non disponible
Produit réglementé par la FDA (É-U):
Yes
IPD Sharing Statement :
???
Responsables de l’étude:
Sponsor
Commanditaires de l’étude:
lead_sponsor
Pfizer
Industry
Collaborators:
???
Chercheurs:
Pfizer CT.gov Call Center Pfizer
Protocol Registration and Results System:
???
Date de vérification:
2024-05-01